CIED Infection Quality Initiative Demonstration Project

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Duke University
Study ID
NCT05471973
Status
Recruiting
Apply to this trial

Conditions

  • Infections

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Multidisciplinary Team — OTHER
    Multidisciplinary team will be established that will define gaps in care, monitor ongoing data, identify barriers to guideline-directed care, and develop and implement multifaceted intervention to address the barriers
  • Outreach Visits — OTHER
    An outreach visit consulting group from the coordinating center and trial leadership will provide external guidance on reviewing data, defining barriers, and implementing interventions
  • Multifaceted Intervention — OTHER
    These interventions are not limited to targeted engagement with non-extractors, electronic health record (EHR) decision support, creation of OR block time, use of opinion leaders, and development of clinical pathways. In addition, once patients are identified and referred to extraction centers, clinical pathways are needed to provide prompt care without clinical delay
  • Measurement and Feedback — OTHER
    The coordinating center will provide ongoing feedback related to the site's data. This will include time to diagnosis, treatment, and outcomes related to the device infection.

Study Details

The aim of this Quality Initiative (QI) demonstration project is to develop a model to increase guideline-driven care for patients with cardiovascular implantable electronic devices (CIED) infection. Multidisciplinary teams will be established to carry out the multifaceted intervention. This program seeks to improve early identification and diagnosis, appropriate treatment, and faster time to treatment of CIED infection.

Key Dates

Start date
May 10, 2023
Status verified
May 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Quality Improvement Program
    The quality improvement program will consist of development and/or refinement of participating health system's patient care pathways tailored to address the gaps and barriers around recognition and treatment of CIED infections. Interventions will be customized and modified as needed based on regular reviews and implementation progress.

Primary Outcome Measure

Proportion of patients with CIEDs and positive blood cultures who receive extraction (per guidelines) [ Time Frame: Up to 12 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
NorthwesternChicagoIllinois60611
Anna Huskin, RN, BSN
Albert Lin, MD (PRINCIPAL_INVESTIGATOR)
Atrium HealthCharlotteNorth Carolina28203
Melissa Myers
Nicole Boisvert
Rohit Mehta, MD (PRINCIPAL_INVESTIGATOR)
Satish Misra, MD (PRINCIPAL_INVESTIGATOR)
Moses ConeGreensboroNorth Carolina27401
Cameron Lambert, MD
Cameron Lambert, MD (PRINCIPAL_INVESTIGATOR)

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